A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 20≤ Age ≤ 70

• Diagnosed with Type I or Type II diabetes

• HbA1c ≤ 11%

• Patients with diabetic neuropathic pain for at least 3 months

• Patients corresponding to average pain level of 4 points or mor for 24 hours evaluated with 11-point Likert scale

Exclusion Criteria:

• Neuropathic pain due to other causes

• Another stronger pain other than neuropathic pain

• Abnormality in blood pressure, weight

• Positive reaction in HIV, HBV or HCV

• A medical history of mental illness within 6 months

• The grade of BDI(Beck Depression Inventory) exceeds 21 points

• History of drug/alcohol abuse